Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease

NCT02739750 | Completed DMC

• 1 other identifier: Indiana U 1511993513
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Kidney Disease (CKD) is associated with bone changes and very high fracture rates. A component of bone is marrow. Bone marrow fat is increased in patients with CKD compared to those in the normal population of the same age. It is not clear if there will be changes in the marrow fact content in those with CKD on Pioglitazone. In people with normal kidney function, thiazolidinedione group of drugs have had variable effects on bone marrow fat content, as measured by MRS. This is important as changes in marrow fat are likely related to changes in the bone in patients with chronic kidney disease.

Conditions

Polycystic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• The percent change in the bone marrow lipid fraction averaged between L2, L3 and L4 at baseline to 12 months and 12 months to 24 months.

  Subjects will undergo and MRI at Baseline, 12 months, and 24 months to measure bone marrow.

  Baseline, 12 months, 24 months

Interventions

No intervention OTHER

There is no intervention for this study. It is a MRS.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

PKD subjects that consent to the FDA study, number 1308084213, will be approached for consenting for this bone marrow fat study. Subject must be enrolled in NCT#02697617

You may not qualify if:

• Male or female ADPKD patients aged 18-55
• eGFR at or above ≥ 50 ml/min/1.73 m2 by 4 parameter MDRD or CKD-Epiformulas
• normal liver enzymes (ALT/AST)
• fasting blood glucose between 70 and120
• for female patients, a willingness to use double contraception to avoid pregnancy while in study
• able to give informed consent
• In the opinion of the investigator, high likelihood of progressive kidney disease
• diabetes, defined as any of the following: fasting blood sugar \> 130 times two, HgbA1C \> 7, on any blood sugar lowering medication, or past diagnosis of diabetes not occurring during pregnancy
• uncontrolled hypertension, defined as systolic \> 150, diastolic \> 90 despite an attempt by physician to titrate medications
• history of impaired systolic function (ejection fraction \< 50%) by previous ECHO or known ischemic cardiovascular disease
• findings suggestive of a kidney disease other than ADPKD
• systemic illness requiring immunosuppressive or anti-inflammatory agents
• congenital absence of a kidney or history of a total nephrectomy
• history of cyst reduction or partial nephrectomy
• history of renal cyst aspiration within the previous year

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Polycystic Kidney Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Ranjani Moorthi, MD

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Nephrology

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 15, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)